The therapy gained approval as a first-line treatment to treat anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer patients in April. It had been used to treat ALK-positive NSCLC patients who had previous treatment with Xalkori (crizotinib) but whose tumors locally advanced or metastasized.

Because ALK-positive NSCLC is a carcinoma arising from the rearrangement of the ALK gene, treatment with ALK inhibitor can suppress tumor cell proliferation and induce its death. Among ALK inhibitors, Alecensa, through its highly selective mechanism, boasts high target activity on the ALK gene, Roche Korea said.

The ALEX study conducted on 303 ALK-positive NSCLC patients who had no previous treatment history showed the efficacy of the drug against crizotinib. Results showed that the Alecensa slashed the risk of disease progression and death by 57 percent. Patients taking alectinib also had a 3-fold improved mean progression-free survival (PFS) length of 34.8 months, showing superior PFS improvements.

According to Professor Ahn Jin-seok from Samsung Medical Center, Department of Hematology & Oncology, who took part in the ALEX study, the therapy proved especially effective for blocking progression of diseases of the central nervous system.

“As is common for most lung cancers, many patients at the time of diagnosis have had their cancers metastasized to the brain. Metastasis is not just limited to one area – more than half have more than four metastases. This causes difficult symptoms for the patient,” Ahn said.

The professor stressed that treatment with alectinib decreased the risk of CNS disease progression by about 84 percent, which would contribute to the increase of cognitive function, exercise ability, and overall quality of life.

Results from the ALEX study showed that those taking Alecensa had a 9.4 percent rate of CNS metastasis while the comparison arm had a 41.4 percent rate. Patients also reported more sustained reports of health-related quality of life compared to the comparison arm, according to Roche Korea.

For these reasons, Ahn stressed, the National Comprehensive Cancer Network has recommended Alecensa as a preferred “Category 1” first-line therapy for ALK-positive NSCLC.